预测复发或转移性鼻咽癌患者接受接下来治疗的PD-1单抗疗法(≥2次疗程)的预后新模型。
A new prognostic model for predicting outcomes of patients with recurrent or metastatic nasopharyngeal carcinoma receiving subsequent line (≥2 lines) anti-programmed death-1 monotherapy.
发表日期:2023 Feb 22
作者:
Su-Chen Li, Shen-Wen Deng, Xue-Song Sun, Kai-Qi Lan, Chun-Yan Guo, Da-Feng Lin, Li-Ting Liu, Sai-Lan Liu, Hai-Qiang Mai, Lin-Quan Tang
来源:
ORAL ONCOLOGY
摘要:
大约17.7-34.0%的复发或转移性鼻咽癌(RM-NPC)患者对抗PD-1单药治疗有良好反应。我们旨在建立一个曲线图,以估计接受随后线抗PD-1单药治疗的RM-NPC患者的无进展生存期(PFS)。这个队列研究调查了连续接受抗PD-1单药治疗的RM-NPC患者。在训练队列(n=161)中使用Cox多元模型进行逆向逐步纳入,开发了一个曲线图,并在验证队列(n=69)中进行了验证。使用一致性指数(C-index)和校准曲线评估其预测准确性。主要终点是PFS。次要终点包括客观反应率(ORR)、疾病控制率(DCR)和总体生存率(OS)。肝转移、白蛋白、乳酸脱氢酶、单核细胞/淋巴细胞比率和血浆EB病毒DNA被用来开发一个曲线图,可以将患者分为有利-不利预后组。训练和验证队列中的C-index分别为0.70和0.68,这一点得到校准曲线的证实。对于不利预后组,中位PFS(mPFS)比有利预后组低(1.80对4.93;危险比2.49[95%置信区间:1.78-3.49];p<0.001),跨所有亚组。OS也表现出相同的模式。ORR和DCR在不利预后组中明显低于有利预后组。所有结果都在验证队列中得到证实。我们的模型是RM-NPC患者接受抗PD-1单药治疗PFS可靠的预后指标,可以强有力地评估个体可能获得的免疫治疗益处。版权所有 © 2023 Elsevier Ltd.保留所有权利。
About 17.7-34.0 % of patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) responded well to anti-PD-1 monotherapy. We sought to establish a nomogram to estimate the progression-free survival (PFS) of RM-NPC patients receiving subsequent-line anti-PD-1 monotherapy.This cohort study investigated consecutive RM-NPC patients undergoing anti-PD-1 monotherapy. A nomogram was developed in the training cohort (n = 161), using a Cox multivariate model with backward stepwise inclusion, and was validated in the validation cohort (n = 69). Its predictive accuracy was assessed using a concordance index (C-index) and calibration curve. The primary endpoint was PFS. Secondary endpoints included the objective response rate (ORR), disease control rate (DCR), and overall survival (OS).Liver metastasis, albumin, lactate dehydrogenase, monocyte-to-lymphocyte ratio, and plasma Epstein-Barr virus DNA were used to develop a nomogram that could separate patients into favourable- and unfavourable-prognosis groups. The C-index in the training and validation cohort were 0.70 and 0.68, respectively, which was confirmed by calibration curves. Median PFS (mPFS) was lower for the unfavourable-prognosis than for the favourable-prognosis group (1.80 vs 4.93; hazard ratio 2.49 [95 % confidence interval: 1.78-3.49]; p < 0.001), across all subgroups. OS exhibited the same pattern. The ORR and DCR were markedly lower in the unfavourable-prognosis than in the favourable-prognosis group. All results were confirmed in the validation cohort.Our model is a reliable prognostic indicator of PFS in RM-NPC patients undergoing anti-PD-1 monotherapy, allowing robust estimation of the immunotherapy benefit an individual might derive.Copyright © 2023 Elsevier Ltd. All rights reserved.